Dydrogesterone treatment for menstrual-cycle regularization in abnormal uterine bleeding-ovulation dysfunction patients

BACKGROUND Dydrogesterone has shown significant efficacy in treatment of irregular menstrual cycle due to abnormal uterine bleeding-ovulation dysfunction(AUB-O),but there were few relevant studies.This observational study was designed to evaluate the effectiveness of dydrogesterone for the treatment of Chinese patients with AUB-O.AIM To evaluate the effects of dydrogesterone on menstrual-cycle(MC)regularization and metabolism in the patients with AUB-O.METHODS A prospective,non-interventional,single-arm,post-marketing observational study was conducted.Chinese women aged 16 years or above with AUB-O who had been prescribed dydrogesterone were enrolled.The patients were treated with dydrogesterone 10 mg from day 16 to day 25 of each cycle,consecutively for at least 3 cycles.The main outcome was defined as the percentage of patients whose MCs returned to normal(defined as 21 d<menstrual cycle≤35 d)after three cycles of dydrogesterone treatment.RESULTS One hundred and fourteen women with AUB-O were enrolled in the present study.Of 89 patients who completed treatment,72(80.9%)achieved a regular MC at the end of the 3rd circle.The level of androgen,including testosterone and dehydroepiandrosterone sulfate,declined significantly(P=0.01 and 0.031,respectively),whereas other hormone levels remained steady.During the treatment,44/80(55.0%)subjects in the per-protocol set had reported biphasic basal body temperature.CONCLUSION Dydrogesterone therapy was effective in achieving MC regularization for Chinese patients with AUB-O.